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Understanding GDPR Compliance in Clinical Trials
Dive into the complexities of GDPR compliance in clinical trials in Contract Pharma’s article, Understanding GDPR Compliance in Clinical Trials, an interview with Laura Gatavs, Head of Legal Department for Rho EU. Explore the nuances of when and where GDPR applies, grasp the basics of compliance – both at company compliance level and when negotiating clinical trial agreements – and uncover essential takeaways and best practices for clinical trial sponsors.
Blog Post
Submitting SAS Programs to FDA
Biometrics teams can generate hundreds, if not thousands, of SAS programs throughout the drug development process. So how do you know which ones to submit to the FDA? And how do you go about submitting the programs?
Blog Post
How to estimate the sample size for your next study from a publication with nothing but p-values and Ns
As statisticians, we’re frequently asked to do power and sample size calculations from very thin data. Often, we’re given nothing but an ancient publication containing a few p-values, an occasional mean, and maybe a standard deviation (if we’re lucky). Back calculating something meaningful in these situations can seem intimidating, but it turns out that most standard sample size software can do the work for us when used unconventionally. We’ve outlined 2 such unconventional uses.
Press Releases
Rho Names HR Expert Pam Myers as Chief People Officer
Rho Names HR Expert Pam Myers as Chief People Officer
Blog Post
Innovative Designs in Early-Stage Studies
Innovation in early-stage studies presents the best opportunity to streamline the drug development process. Such designs may not only reduce costs and accelerate timelines but give us better flexibility to address the questions of interest in an increasingly evolving clinical development landscape.
Blog Post
Transitioning Trials Approved under the Clinical Trials Directive to the Clinical Trials Regulation and CTIS
The new European Union (EU) legislation regulating clinical trials harmonises the processes for assessment and supervision of clinical trials throughout the EU. It enables sponsors to submit 1 online application via a single platform (CTIS) for approval to run a clinical trial in several European countries, making the conduct of such multinational trials more efficient.
Blog Post
Planning for a Successful Centralised Marketing Authorisation Application in the European Union
In the dynamic landscape of pharmaceuticals, obtaining a centralised marketing authorisation in the European Union (EU) is a crucial step for companies looking to bring their medicines to a broad market. The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorizations in the EU, offering a streamlined process that enables companies to submit a single marketing authorisation application (MAA) and to market their products across the entire European Economic Area (EEA), which includes the EU countries, Iceland, Norway and Liechtenstein, based on a single authorisation.
Blog Post
How Many Strata can my Randomized Clinical Trial have?
When running a randomized clinical trial, if there are factors which are known during the study design phase to influence study results, it may be advantageous to utilize a stratified randomization which ensures each prognostic factor is balanced between treatment arms.
News
Tonix Pharmaceuticals Announces Engagement of Rho as CRO to Support Submission of New Drug Application to the FDA for Approval of Tonmya™ for the Management of Fibromyalgia
Rho is thrilled to announce our unwavering support for Tonix Pharmaceuticals as they prepare to submit their New Drug Application (NDA). Serving as a dedicated partner to Tonix, we are committed to providing the necessary resources and expertise to support the next steps toward regulatory approval of Tonmya™ for the management of fibromyalgia. Our collaboration underscores our shared dedication to advancing healthcare solutions that improve patient outcomes and enhance the quality of life. We are grateful to be a part of such an exciting partnership as we continue to champion breakthrough advancements in drug development.
Blog Post
Handling Efficacy Data in Long-Term Ongoing Studies for a Submission
Regulatory reviewers will expect a Clinical Study Report (CSR) and supporting electronic data packages for these studies, but that doesn’t have to delay our filing date. We have outlined suggested techniques to provide the agency with everything they need to review the application, without compromising the integrity of the ongoing study.